Scientists Advancing Affordable Medicines, Inc. is a nonprofit (tax-exempt status pending) organization that seeks to provide a dedicated platform for scientists to share cutting-edge research that facilitates the development of high-quality, affordable medicines, thereby improving their accessibility to patients. Because we are sharing approaches now for the affordable medicines of tomorrow, we have adopted the tradename SAAMnow.
Annual Scientific Workshop
Streamlining Generic Drug Development by Matching Reference Product Composition and Performance, In Vitro and In Vivo
Our inaugural workshop held October 18-19, 2018, in Baltimore, MD, addressed the issues surrounding reverse engineering methods and strategies in the context of Q1/Q2/Q3 comparisons, with an eye toward reducing the clinical burden of generic drug development programs via BCS class 3 biowaivers, in vitro-only pathways for locally-acting and complex drug products, and, where biowaivers are not possible, streamlining complex human bioequivalence studies. The program was developed to appeal to stakeholders across a broad range of disciplines and to span a diverse group of product classes.
SAAMnow offers individuals the opportunity to potentially impact the availability of affordable medicines through cutting-edge research. SAAMnow is looking for individuals involved/interested in research & development, formulation/manufacturing science, analytical chemistry, clinical science, statistics, quality systems, regulatory science, marketing, and allied disciplines associated with the development, manufacturing, testing, and commercialization of high quality affordable medicines. Affordable medicines are broadly defined as those that take advantage of abbreviated regulatory filing pathways, resulting in development cost savings that can then be passed on to patients. Examples include conventional generic pharmaceuticals, biosimilars, and products filed via hybrid regulatory pathways, such as the 505(b)(2) route.